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NCT02567656 · OUTCOME

Peak Plasma Concentration (Cmax)

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma · Source last updated 2020-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Cycle 1

What was measured

Peak Plasma Concentration (Cmax) of RP6530

Analysis population: Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1

Groups in this outcome

Dose escalation_Cohort 1_200 mg

RP6530 administered 200 mg orally twice a day.

Dose escalation_Cohort 2_400 mg

RP6530 administered 400 mg orally twice a day.

Dose escalation_Cohort 3_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

Dose escalation_Cohort 4_800 mg (Fed)

RP6530 administered 800 mg orally twice a day under fed condition

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose escalation_Cohort 1_200 mg4
Dose escalation_Cohort 2_400 mg4
Dose escalation_Cohort 3_800 mg (Fasting)5
Dose escalation_Cohort 4_800 mg (Fed)6

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose escalation_Cohort 1_200 mg1297.65622.81Not reportedNot reportedNot reported
Dose escalation_Cohort 2_400 mg2196.65676.45Not reportedNot reportedNot reported
Dose escalation_Cohort 3_800 mg (Fasting)3995.681392.74Not reportedNot reportedNot reported
Dose escalation_Cohort 4_800 mg (Fed)2668.051713.17Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        622.81
        value
        1297.65
      2. group Id
        OG001
        spread
        676.45
        value
        2196.65
      3. group Id
        OG002
        spread
        1392.74
        value
        3995.68
      4. group Id
        OG003
        spread
        1713.17
        value
        2668.05
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Peak Plasma Concentration (Cmax) of RP6530
dispersion Type
Standard Deviation
groups
  1. description
    RP6530 administered 200 mg orally twice a day.
    id
    OG000
    title
    Dose escalation_Cohort 1_200 mg
  2. description
    RP6530 administered 400 mg orally twice a day.
    id
    OG001
    title
    Dose escalation_Cohort 2_400 mg
  3. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    OG002
    title
    Dose escalation_Cohort 3_800 mg (Fasting)
  4. description
    RP6530 administered 800 mg orally twice a day under fed condition
    id
    OG003
    title
    Dose escalation_Cohort 4_800 mg (Fed)
param Type
MEAN
population Description
Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1
reporting Status
POSTED
time Frame
Day 1 of Cycle 1
title
Peak Plasma Concentration (Cmax)
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice